Canesten Thrush Combi Pessary and External Cream 500mg/2% w/w

Država: Malta

Jezik: engleski

Izvor: Malta Medicines Authority

Aktivni sastojci:

CLOTRIMAZOLE

Dostupno od:

Bayer PLC

ATC koda:

G01AF18

INN (International ime):

CLOTRIMAZOLE

Farmaceutski oblik:

VAGINAL CREAM VAGINAL TABLET

Sastav:

CLOTRIMAZOLE 2 % (W/W)

Tip recepta:

OTC

Područje terapije:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Status autorizacije:

Authorised

Datum autorizacije:

2006-03-02

Uputa o lijeku

PMR 82095748 (O8/03) Pantone: 485, Cool Gray 11
0
THRUSH COMBI PESSARY &
EXTERNAL CREAM
500mg pessary & 2% w/w cream
Clotrimazole
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to
use Canesten Thrush Combi Pessary & External Cream carefully to get
the best results from it.
•
Keep this leafet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not
improve in 7 days.
•
If you have any unusual effects after using this product, tell your
doctor or pharmacist.
IN THIS LEAFLET
1.
What is Canesten Thrush Combi and what is it used for?
2.
Before you use Canesten Thrush Combi
3.
How to use Canesten Thrush Combi
4.
Possible side effects
5.
How to store Canesten Thrush Combi
6.
Further information
1.
WHAT IS CANESTEN® THRUSH COMBI AND
WHAT IS IT USED FOR?
Canesten Thrush Combi Pessary & External Cream is a complete
treatment for vaginal thrush because it treats both the internal cause
and
external symptoms.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING VAGINAL THRUSH.
The active substance in Canesten Thrush Combi is clotrimazole.
Clotrimazole belongs to a group of medicines called azoles and is an
antifungal agent which fights the cause of infections such as vaginal
thrush.
2. BEFORE YOU USE CANESTEN®
THRUSH COMBI
DO NOT USE CANESTEN THRUSH COMBI PESSARY & EXTERNAL CREAM:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other
ingredients, including cetostearyl alcohol, of Canesten Thrush Combi
Pessary & External Cream (_see Section 6. Further Information_).
•
During your period as it may be less effective.
•
To treat nail and scalp infections.
BEFORE USING CANESTEN
® THRUSH COMBI PESSARY & EXTERNAL
CREAM, YOU SHOULD SEE YOUR DOCTOR IF:
•
You are unsure whether you have thrush or this is the first time you
have had these symptoms.
•
You h

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Canesten Thrush Combi Pessary & External Cream 500mg / 2% w/w pessary
& cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Canesten Thrush Pessary contains Clotrimazole 500mg.
Canesten Thrush External Cream contains Clotrimazole 2% w/w.
Excipient with known effect:
Cream: cetostearyl alcohol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pessary and cream
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The pessary is recommended for the treatment of candidal vaginitis.
The cream is recommended for the treatment of candidal vulvitis. It
should be
used as an adjunct to treatment of candidal vaginitis.
These products should only be used if candidal vulvovaginitis (thrush)
was
previously diagnosed by a doctor.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
.
Adults
One pessary should be inserted into the vagina at night. Using the
applicator
provided, the pessary should be inserted as high as possible into the
vagina.
This is best achieved when lying back with legs bent up.
Canesten pessaries need moisture in the vagina in order to dissolve
completely,
otherwise undissolved pieces of the pessary might crumble out of the
vagina.
Pieces of undissolved pessary may be noticed by women who experience
vaginal
dryness. To help prevent this it is important that the pessary is
inserted as high as
possible in to the vagina at bedtime.
Treatment during the menstrual period should be avoided due to the
risk of the
pessary being washed out by the menstrual flow. The treatment should
be
finished before the onset of menstruation.
2
Do not use tampons, intravaginal douches, spermicides or other vaginal
products while using this product.
The cream should be thinly applied to the vulva and surrounding area,
two or
three times daily and rubbed in gently.
Treatment with the cream should be continued until symptoms of the
infection
disappear.
However,
if
after
concomitant
treatment
of
the
vaginitis,
the
symptoms do not improve within seven day